NCT02397395

An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen R&D Ireland · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

Detailed description

This is a Phase 2, open-label (identity of study drug will be known to volunteer and study staff), single-arm, multicenter (when more than one hospital work on a medical research study) study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 12 weeks treatment with Simeprevir (SMV) and Daclatasvir (DCV) in participants with chronic Hepatitis C Virus (HCV) genotype 1b or 4 infection and either severe renal impairment or End-stage Renal Disease on hemodialysis. The study consists of a Screening Phase of 4 weeks, an Open-label Treatment Phase of 12 weeks, and a post-Treatment Follow-up Phase of 24 weeks. The total study duration for each participant will be approximately 40 weeks. All participants will receive a treatment regimen consisting of SMV 150 mg and DCV 60 mg co-administered once daily for a total treatment duration of 12 weeks. Participants who experience inadequate virologic response at Week 8 (defined as confirmed HCV RNA greater than or equal to \[\>=\] lower limit of quantification \[LLOQ\]) or viral breakthrough at any on-treatment visit (defined as confirmed increase in HCV RNA of \>1 log base 10 from nadir, or confirmed HCV RNA \>100 International unit per milliliter \[IU/mL\] in participants whose HCV RNA had previously been \<LLOQ while on treatment) should discontinue all study drugs. Participants will be primarily evaluated for sustained virologic response 12 weeks after the actual end of study treatment (SVR12). Participants' safety will be evaluated throughout the study duration.

Conditions

• Renal Impairment
• End-stage Renal Disease

Interventions

Type	Name	Description
DRUG	Simeprevir (SMV) 150 mg	Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.
DRUG	Daclatasvir (DCV) 60 mg	Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2015-03-25
• Last updated: 2015-07-17

Locations

6 sites across 2 countries: France, Spain